ABSTRACT

The United States Pharmacopeia (USP) is not the only body setting standards for drug packaging. In addition to the information contained in the USP, the Food and Drug Administration (FDA) and the Consumer Product Safety Commission (CPSC) set packaging guidelines and regulations. This entry is meant to serve as a framework for the understanding of compendial requirements for pharmaceutical packaging practice, and as such, will focus on standards contained in the USP and National Formulary (NF).